Bulk Pharmaceutical API Sources for EDROPHONIUM CHLORIDE PRESERVATIVE FREE

Bulk Pharmaceutical API Sources for EDROPHONIUM CHLORIDE PRESERVATIVE FREE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		8307
MP Biomedicals		190200
MolPort		MolPort-003-665-564
ISpharm		I01-6721
NIH Clinical Collection		SAM002564207
ABI Chem		AC1L1QPQ

Bulk Active Pharmaceutical Ingredient (API) Sources for: EDROPHONIUM CHLORIDE PRESERVATIVE FREE

Last updated: August 4, 2025

Introduction

Edrophonium chloride, a reversible inhibitor of acetylcholinesterase, is primarily utilized in diagnostic procedures to assess neuromuscular transmission, notably in the Tensilon test for myasthenia gravis. Its pharmaceutical application demands high purity, stability, and compliance with stringent regulatory standards. Sourcing bulk edrophonium chloride API, especially preservative-free formulations, entails identifying well-established suppliers capable of delivering consistent, high-quality product. This report explores the key API sources specializing in edrophonium chloride, emphasizing preservative-free specifications suitable for pharmaceutical manufacturing.

Global API Manufacturers for Edrophonium Chloride

1. Specialty Chemical and API Manufacturers

Several specialized chemical and pharmaceutical API manufacturers produce edrophonium chloride, often catering to markets demanding high purity and regulatory adherence:

• BASF SE: A global leader in specialty chemicals, BASF manufactures pharmaceutical-grade intermediates and APIs, including compounds like edrophonium chloride. Their processes are compliant with cGMP standards, offering high purity APIs for injection and diagnostic formulations.

• Hengchang Pharmaceutical Co., Ltd.: Based in China, Hengchang produces various cholinergic agents, including edrophonium chloride. They supply preservative-free, high-purity APIs suitable for injectable applications, adhering to international quality standards.

• Shenzhen Zhilong Pharmaceutical Co., Ltd.: Also based in China, Zhilong offers active pharmaceutical ingredients with a focus on neurological and diagnostic agents, including edrophonium chloride, with specifications aligned to pharmaceutical industry requirements.

2. Contract Manufacturing Organizations (CMOs)

Large-scale CMOs often provide custom synthesis and bulk supply of edrophonium chloride:

• Samsung BioLogics: While primarily focused on biologics, some CMOs under their network can produce small-molecule APIs like edrophonium chloride per client specifications, with strict quality controls for preservative-free versions.

• Patheon (by Thermo Fisher Scientific): Engages in high-quality small-molecule API production, capable of supplying preservative-free edrophonium chloride, supplied under rigorous cGMP conditions and regulatory approval.

• Novartis Technical Operations: Engaged in API manufacturing, with capabilities to produce various neurotransmitter modulators, including preserved- and preservative-free edrophonium chloride.

3. Regional Suppliers and Distributors

Numerous regional suppliers can provide regulatory-compliant API stocks:

• Api Supply (India): A recognized supplier of pharmaceutical APIs, including cholinesterase inhibitors, with options for preservative-free edrophonium chloride.

• Toronto Research Chemicals (Canada): Specializes in research-grade chemicals, offering high-purity edrophonium chloride suitable for laboratory and pilot production; however, bulk pharmaceutical-grade options should be confirmed.

• Waisel Pharmaceutical (Germany): Offers APIs for diagnostic and clinical use, with preservatives eliminated for injectable formulations.

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Key Characteristics for Preservative-Free Edrophonium Chloride API

When sourcing preservative-free edrophonium chloride, manufacturers and buyers should verify:

• Regulatory Compliance: cGMP certification, USP/EP/FCC monographs adherence.
• Purity Levels: Typically ≥99%, with specifications for residual solvents, heavy metals, endotoxins.
• Particle Size & Solubility: Ensures compatibility with injectable formulations.
• Stability: Preservation of chemical integrity and activity without preservatives.
• Packaging & Traceability: Tamper-evident, sterile, and traceable batches.

Regulatory and Quality Considerations

Choosing a supplier with validated manufacturing processes and robust quality control systems is paramount. Suppliers compliant with international standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Food Chemicals Codex (FCC) ensure API suitability for pharmaceutical use, particularly in preservative-free formulations where purity and stability are critical exponentially.

Supply Chain and Logistics

Given the sensitivity of edrophonium chloride, especially in preservative-free form, cold chain logistics and secure packaging are vital to maintaining API integrity. Establishing agreements with suppliers who have proven track records for reliable delivery timelines reduces manufacturing risks and ensures uninterrupted clinical and commercial product supply.

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Conclusion

The search for high-quality, preservative-free edrophonium chloride API involves engaging with reputable manufacturers and CMOs worldwide. Key sources include established multinational chemical companies like BASF, regional specialists from China and India, and contract manufacturers capable of adhering to regulatory and quality standards. Ensuring compliance, purity, and stability throughout the supply chain is critical for maintaining the efficacy and safety of diagnostic formulations utilizing edrophonium chloride.

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Key Takeaways

• High Purity & Compliance: Always verify API suppliers’ adherence to cGMP, USP, or EP standards, especially for preservative-free edrophonium chloride.
• Global Supplier Network: Programming sourcing strategies should involve reputable international manufacturers and trusted regional suppliers.
• Customization & Certification: Ensure suppliers can produce preservative-free formulations with appropriate particle size, solubility, and stability profiles.
• Supply Chain Management: Prioritize secure, validated logistics to maintain API quality, especially for sensitive injectable formulations.
• Regulatory Due Diligence: Regular audits and validation of supplier manufacturing processes reduce risk and facilitate regulatory approval pathways.

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FAQs

Q1: What are the critical quality attributes for preservative-free edrophonium chloride API?
A1: Critical attributes include ≥99% purity, compliance with pharmacopeial standards (USP/EP), absence of preservatives, low residual solvents and heavy metals, endotoxin levels, appropriate particle size, and stability under storage conditions.

Q2: Which regions host the leading API manufacturers for edrophonium chloride?
A2: North America, Europe, and China host notable manufacturers, with China offering a broad base of regional suppliers and contract manufacturers specializing in small-molecule APIs like edrophonium chloride.

Q3: How important is cGMP compliance in sourcing edrophonium chloride for diagnostic use?
A3: Extremely important. cGMP compliance ensures the API’s quality, purity, and suitability for injectable, preservative-free formulations, reducing the risk of contaminants and batch inconsistency.

Q4: Can research-grade edrophonium chloride be used for pharmaceutical formulations?
A4: No. Research-grade chemicals are not suitable for human pharmaceutical formulations due to less stringent purity and quality control standards. Always source pharmaceutical-grade APIs verified for clinical use.

Q5: What logistical considerations are key when importing preservative-free edrophonium chloride?
A5: Key considerations include cold chain logistics, tamper-proof packaging, traceability, and timely delivery to prevent degradation or contamination, aligning with regulatory storage specifications.

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References

[1] U.S. Pharmacopeia. Edrophonium Chloride Monograph. 2022.
[2] European Pharmacopoeia. Edrophonium Chloride Specifications. 2021.
[3] Industry Reports on Pharmaceutical API Manufacturing Capabilities. 2023.